1. Field of the Invention
This invention relates to means for treatment of renal decline and failure. It is particularly directed to an improved system for ambulatory transfer of dialysate to and from the peritoneum.
2. State of the Art
Medical practice has numerous applications for treatment of impaired renal function and ultimate decline and failure with peritoneal dialysis. The application of peritoneal dialysis, involves introduction of a dialysate solution to the peritoneal cavity outside the omentum, through an indwelling single lumen catheter entering the peritoneum through the abdominal wall near the pelvis. The dialysate remains within the peritoneum for approximately four hours until osmotic diffusion of bodily wastes from a renal patient through the semipermeable epithelial tissues approaches an equilibrium of saturation in the dialysate. At some point within this terminal range of approach the dialysate is functionally exhausted and is transferred out of the peritoneum and exchanged for a new infusion of unused dialysate.
Existing peritoneal dialysis systems suffer from any of a number of disadvantages. Most devices require the patient to be tethered and confined and to be situated at a fixed location with a dializing bag hanging from an IV stand for gravity feed throughout the transfer of dialysate to and from the peritoneum of the patient and do not permit ambulation during transfer of dialysate. Some systems utilize pumps that have the disadvantages of substantial cost, size and weight that are prohibitive of significant ambulation during dialysate transfer.
Irrespective of which paradigm has been used, heretofore, peritoneal dialysis procedures presuppose introduction and maintenance of a total of approximately three liters or twelve pounds of dialysate solution to and within the peritoneum for an extended period of time for the patient, with the epithelial tissues of the peritoneum acting essentially as an artificial kidney; the process uncomfortably expands and distends the abdomen of the patient and results in discomfort, disfigurement, flatulence and inconvenience. These disadvantages are virtually continuous from the inception of each dialysis treatment.
Prior art devices for containment of dialysate bags for gravity flow have heretofore been available exclusively for attachment to IV stands adjacent to the patient's person, precluding comfort in movement such as standing, walking or other ambulation and other positions and activities and, further also, detracting from the aesthetic appeal to the patient and diminishment of the patient's body balance and self-image.
Previous peritoneal dialysis processes only crudely infer the terminal range within which dialysate has approached equilibrium, is exhausted and to be exchanged for unused dialysate. The inference is drawn from historic norms of a broad population despite potentially substantial variances from one individual to another.
A related disadvantage of prior art peritoneal dialysis is the deleterious effect on surrounding epithelial tissues from extended exposure to dialysate that is saturated with caustic bodily toxins. Upon diagnosis of end stage renal failure, the present prognosis is between two and three years life expectancy, due in large measure to the continuous unnaturally high exposure of these sensitive tissues to noxious bodily wastes within exhausted dialysate.
Heretofore, inefficiencies have resulted from infusion of excessive or insufficient amounts of dialysate relative to the needs of the particular patient during a particular time frame. Similarly, dialysate infused in ideal amounts but incorrectly presumed to be exhausted is occasionally discarded prematurely.
There is a need for a dialysis system providing ambulatory, unobtrusive, light weight, symmetric, orientation-neutral and convenient storage and containment of new or exhausted dialysate and associated systems.
A further need exists for such a renal treatment system with single patient components that are inexpensive, disposable and sufficiently simple for use in a home care or ambulatory environment.
There remains a need for an improved peritoneal dialysis system wherein electronic circuitry and associated indicators enable monitoring of the solute and regulation of flow rates, including system pressures, temperature, system timing, chemical balances and other therapeutic variables to more closely mimic and optimize normal physiological patterns and to enhance the patient's and physician's ability to determine optimal dosage, regime and protocol to obtain such goals.
There exists a need for such monitoring and regulation optionally from locations remote from the patient. Whether remote or not, there is a continuing need for the foregoing features that may be actuated automatically or by direct intervention based on real time interaction.
Further yet, there is a need for a peritoneal dialysis system closely customized to the circumstances of a particular patient enabling a more accurate determination of the terminal point at which exhausted dialysate is to be reconditioned or transferred from the patient and exchanged for unused dialysate or, if practicable, reconditioned dialysate.